Robot-Assisted Prostate Biopsy With a Novel Ultrasound Probe

Johns Hopkins University

Status and phase: Enrolling; Phase 1

Conditions: Prostate Cancer (Diagnosis)

Treatments: Device: Prostate biopsy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07271017

R01CA303859 (U.S. NIH Grant/Contract)

IRB00229568

Details and patient eligibility

About

Prostate cancer (PCa) is the most diagnosed type of cancer and the second leading cause of cancer related deaths among US men, and its incidence has increased steadily in the last decade. Efforts to address the rise in PCa diagnosis without overdetection and overtreatment include targeted biopsy techniques for clinically significant PCa using magnetic resonance imaging (MRI), and precision targeted biopsy guided by ultrasound and fused to the MRI.

The study aims to improve prostate biopsy with a novel ultrasound probe and robot developed at Johns Hopkins, the ProBot device. The trial is a Phase 1 clinical trial to evaluate the safety and feasibility of the new device.

ProBot is an entirely new concept including a novel ultrasound probe and robot kinematics specifically designed for the prostate. It operates with only two degrees of freedom configured such that the motions for 3D image scanning and biopsy may not deform the prostate gland, thus improving the accuracy of MRI-ultrasound fusion and needle targeting at biopsy.

ProBot is a small and lightweight robot (1.3Kg including the ultrasound probe). It allows hands-free operation of its ultrasound probe at 3D image scanning and needle targeting supervised by the urologist.

In addition to MRI-targeted biopsy (TB), at systematic biopsy (SB), instead of using the common template plan that is the same for all patients, the innovative software optimizes the plan for each patient to obtain a diagnosis that is representative of the whole gland histology. The ProBot robot is also uniquely capable of transrectal (TR) and transperineal (TP) biopsy.

The aims of the study are to determine the safety and feasibility of the new device at TR and TP biopsies.

Enrollment: 60 estimated patients

Sex: Male

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Included in the study will be:

• Men between the ages of 40 and 75

• Men must have one of the following "high risk" features:

  1. PSA > 4.0 ng/ml and/or abnormal digital rectal examination (DRE)
  2. ASAP (atypical small acinar proliferation) on previous biopsy

• Men with mpMRI or bpMRI exams, including both PI-RADS ≤2 and PI-RADS ≥3.

Excluded from the study will be patients without available mpMRI exams and patients:

• Females and children because of the prostate cancer targeted disease.

• Patients who are not recommended or in whom TR or TP prostate biopsy is considered high-risk:

  1. Patients with previous rectal surgery.
  2. Patients with anal stenosis or coagulopathy.
  3. Patients on active anticoagulation medication (eg. Coumadin, Lovenox, or Heparin).
  4. Patients who cannot tolerate periprostatic Lidocaine block anesthesia or in whom anesthesia is considered high-risk.

• Patients who already had a prostate biopsy taken with the ProBot investigational device.

• Vulnerable populations, such as prisoners, institutionalized individuals.

• Patients who are unwilling or unable to sign informed consent (no assent required).

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Transrectal biopsy (TR)

Experimental group

Description:

Biopsy guided by transrectal ultrasound fused with MRI and needle inserted on a transrectal path

Treatment:

Device: Prostate biopsy

Transperineal biopsy (TP)

Experimental group

Description:

Biopsy guided by transrectal ultrasound fused with MRI and needle inserted on a transperineal path.

Treatment:

Device: Prostate biopsy